Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT

Background Venous ulceration is a common and costly health-care issue worldwide, with poor healing rates greatly affecting patient quality of life. Compression bandaging has been shown to improve healing rates and reduce recurrence, but does not address the underlying cause, which is often superficial venous reflux. Surgical correction of the reflux reduces ulcer recurrence; however, the effect of early endovenous ablation of superficial venous reflux on ulcer healing is unclear. Objectives To determine the clinical effectiveness and cost-effectiveness of compression therapy with early endovenous ablation of superficial venous reflux compared with compression therapy with deferred endovenous ablation in patients with venous ulceration. Design A pragmatic, two-arm, multicentre, parallel-group, open randomised controlled trial with a health economic evaluation. Setting Secondary care vascular centres in England. Participants Patients aged ≥ 18 years with a venous leg ulcer of between 6 weeks’ and 6 months’ duration and an ankle–brachial pressure index of ≥ 0.8 who could tolerate compression and were deemed suitable for endovenous ablation of superficial venous reflux. Interventions Participants were randomised 1 : 1 to either early ablation (compression therapy and superficial endovenous ablation within 2 weeks of randomisation) or deferred ablation (compression therapy followed by endovenous ablation once the ulcer had healed). Main outcome measures The primary outcome measure was time from randomisation to ulcer healing, confirmed by blinded assessment. Secondary outcomes included 24-week ulcer healing rates, ulcer-free time, clinical success (in addition to quality of life), costs and quality-adjusted life-years (QALYs). All analyses were performed on an intention-to-treat basis. Results A total of 450 participants were recruited (224 to early and 226 to deferred superficial endovenous ablation). Baseline characteristics were similar between the two groups. Time to ulcer healing was shorter in participants randomised to early superficial endovenous ablation than in those randomised to deferred ablation [hazard ratio 1.38, 95% confidence interval (CI) 1.13 to 1.68; p = 0.001]. Median time to ulcer healing was 56 (95% CI 49 to 66) days in the early ablation group and 82 (95% CI 69 to 92) days in the deferred ablation group. The ulcer healing rate at 24 weeks was 85.6% in the early ablation group, compared with 76.3% in the deferred ablation group. Median ulcer-free time was 306 [interquartile range (IQR) 240–328] days in the early ablation group and 278 (IQR 175–324) days in the deferred endovenous ablation group (p = 0.002). The most common complications of superficial endovenous ablation were pain and deep-vein thrombosis. Differences in repeated measures of Aberdeen Varicose Vein Questionnaire scores (p < 0.001), EuroQol-5 Dimensions index values (p = 0.03) and Short Form questionnaire-36 items body pain (p = 0.05) over the follow-up period were observed, in favour of early ablation. The mean difference in total costs between the early ablation and deferred ablation groups was £163 [standard error (SE) £318; p = 0.607]; however, there was a substantial and statistically significant gain in QALY over 1 year [mean difference between groups 0.041 (SE 0.017) QALYs; p = 0.017]. The incremental cost-effectiveness ratio of early ablation at 1 year was £3976 per QALY, with a high probability (89%) of being more cost-effective than deferred ablation at conventional UK decision-making thresholds (currently £20,000 per QALY). Sensitivity analyses using alternative statistical models give qualitatively similar results. Limitations Only 7% of screened patients were recruited, treatment regimens varied significantly and technical success was assessed only in the early ablation group. Conclusions Early endovenous ablation of superficial venous reflux, in addition to compression therapy and wound dressings, reduces the time to healing of venous leg ulcers, increases ulcer-free time and is highly likely to be cost-effective. Future work Longer-term follow-up is ongoing and will determine if early ablation will affect recurrence rates in the medium and long term. Trial registration Current Controlled Trials ISRCTN02335796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 24. See the NIHR Journals Library website for further project information.

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A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study

Health Technology Assessment ◽

10.3310/hta20640 ◽

2016 ◽

Vol 20 (64) ◽

pp. 1-86 ◽

Cited By ~ 5

Author(s):

Rebecca K Simmons ◽

Knut Borch-Johnsen ◽

Torsten Lauritzen ◽

Guy EHM Rutten ◽

Annelli Sandbæk ◽

...

Keyword(s):

Risk Factors ◽

Patient Reported Outcomes ◽

Cost Effective ◽

Well Being ◽

Health Technology ◽

Patient Reported ◽

All Cause Mortality

BackgroundIntensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain.ObjectiveTo quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes.DesignPragmatic, multicentre, cluster-randomised, parallel-group trial.SettingThree hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK.ParticipantsIndividuals aged 40–69 years with screen-detected diabetes.InterventionsScreening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol.Main outcome measuresThe primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3;©Isis Innovation Ltd 2010; seewww.dtu.ox.ac.uk/outcomesmodel(accessed 27 January 2016)].ResultsWe included 3055 (RC,n = 1377; IT,n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient.ConclusionsCompared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted.Trial registrationClinicalTrials.gov NCT00237549.Funding detailsThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

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Positive behaviour support training for staff for treating challenging behaviour in people with intellectual disabilities: a cluster RCT

Health Technology Assessment ◽

10.3310/hta22150 ◽

2018 ◽

Vol 22 (15) ◽

pp. 1-110 ◽

Cited By ~ 8

Author(s):

Angela Hassiotis ◽

Michaela Poppe ◽

Andre Strydom ◽

Victoria Vickerstaff ◽

Ian Hall ◽

...

Keyword(s):

Technology Assessment ◽

Cost Effective ◽

Health Technology ◽

Service Users ◽

Challenging Behaviour ◽

The Mean ◽

Secondary Outcomes ◽

Positive Behaviour Support

Background Preliminary studies have indicated that training staff in Positive Behaviour Support (PBS) may help to reduce challenging behaviour among people with intellectual disability (ID). Objective To evaluate whether or not such training is clinically effective in reducing challenging behaviour in routine care. The study also included longer-term follow-up (approximately 36 months). Design A multicentre, single-blind, two-arm, parallel-cluster randomised controlled trial. The unit of randomisation was the community ID service using an independent web-based randomisation system and random permuted blocks on a 1 : 1 allocation stratified by a staff-to-patient ratio for each cluster. Setting Community ID services in England. Participants Adults (aged > 18 years) across the range of ID with challenging behaviour [≥ 15 Aberrant Behaviour Checklist – Community total score (ABC-CT)]. Interventions Manual-assisted face-to-face PBS training to therapists and treatment as usual (TAU) compared with TAU only in the control arm. Main outcome measures Carer-reported changes in challenging behaviour as measured by the ABC-CT over 12 months. Secondary outcomes included psychopathology, community participation, family and paid carer burden, family carer psychopathology, costs of care and quality-adjusted life-years (QALYs). Data on main outcome, service use and health-related quality of life were collected for the 36-month follow-up. Results A total of 246 participants were recruited from 23 teams, of whom 109 were in the intervention arm (11 teams) and 137 were in the control arm (12 teams). The difference in ABC-CT between the intervention and control arms [mean difference –2.14, 95% confidence interval (CI) –8.79 to 4.51; p = 0.528] was not statistically significant. No treatment effects were found for any of the secondary outcomes. The mean cost per participant in the intervention arm was £1201. Over 12 months, there was a difference in QALYs of 0.076 in favour of the intervention (95% CI 0.011 to 0.140 QALYs) and a 60% chance that the intervention is cost-effective compared with TAU from a health and social care cost perspective at the threshold of £20,000 per QALY gained. Twenty-nine participants experienced 45 serious adverse events (intervention arm, n = 19; control arm, n = 26). PBS plans were available for 33 participants. An independent assessment of the quality of these plans found that all were less than optimal. Forty-six qualitative interviews were conducted with service users, family carers, paid carers and service managers as part of the process evaluation. Service users reported that they had learned to manage difficult situations and had gained new skills, and carers reported a positive relationship with therapists. At 36 months’ follow-up (n = 184), the mean ABC-CT difference between arms was not significant (–3.70, 95% CI –9.25 to 1.85; p = 0.191). The initial cost-effectiveness of the intervention dissipated over time. Limitations The main limitations were low treatment fidelity and reach of the intervention. Conclusions Findings from the main study and the naturalistic follow-up suggest that staff training in PBS as delivered in this study is insufficient to achieve significant clinical gains beyond TAU in community ID services. Although there is an indication that training in PBS is potentially cost-effective, this is not maintained in the longer term. There is increased scope to develop new approaches to challenging behaviour as well as optimising the delivery of PBS in routine clinical practice. Trial registration This study is registered as NCT01680276. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 15. See the NIHR Journals Library website for further project information.

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Ulcus cruris venosum: Was bringt die frühzeitige endovenöse Ablation bei venösen Ulzerationen?

Karger Kompass Dermatologie ◽

10.1159/000521763 ◽

2022 ◽

pp. 1-2

Author(s):

Markus Stücker

Keyword(s):

Early Intervention ◽

Intervention Group ◽

Cost Effective ◽

Quality Adjusted Life Year ◽

Ulcer Recurrence ◽

Venous Reflux ◽

Endovenous Ablation ◽

Quality Adjusted Life ◽

Early Intervention Group

Importance: One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. Objective: To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Design, Setting, and Participants: Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months’ duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Interventions: Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. Main Outcomes and Measures: The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. Results: The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57–1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480–0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12–1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Conclusions and Relevance: Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. Trial Registration: ClinicalTrials.gov identifier: ISRCTN02335796.

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How I treat postthrombotic syndrome

Blood ◽

10.1182/blood-2009-07-199174 ◽

2009 ◽

Vol 114 (21) ◽

pp. 4624-4631 ◽

Cited By ~ 101

Author(s):

Susan R. Kahn

Keyword(s):

Risk Factors ◽

Compression Therapy ◽

Postthrombotic Syndrome ◽

Compression Stockings ◽

Venous Ulceration ◽

Long Term Prognosis ◽

Socioeconomic Consequences

AbstractPostthrombotic syndrome (PTS) is a chronic complication of deep venous thrombosis (DVT) that reduces quality of life and has important socioeconomic consequences. More than one-third of patients with DVT will develop PTS, and 5% to 10% of patients will develop severe PTS, which may manifest as venous ulceration. The principal risk factors for PTS are persistent leg symptoms 1 month after the acute episode of DVT, extensive DVT, recurrent ipsilateral DVT, obesity, and older age. Daily use of elastic compression stockings (ECSs) for 2 years after proximal DVT appears to reduce the risk of PTS; however, there is uncertainty about optimal duration of use and compression strength of ECSs and the magnitude of their effect. The cornerstone of managing PTS is compression therapy, primarily using ECSs. Venoactive medications such as aescin and rutoside may provide short-term relief of PTS symptoms. The likelihood of developing PTS after DVT should be discussed with patients, and symptoms and signs of PTS should be monitored during clinical follow-up. Further studies to elucidate the pathophysiology of PTS, to identify clinical and biologic risk factors, and to test new preventive and therapeutic approaches to PTS are needed to ultimately improve the long-term prognosis of patients with DVT.

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A randomised controlled clinical trial comparing the effectiveness of bandaging compared to the JuxtaCures™ device in the management of people with venous ulceration: Feasibility study

Phlebology The Journal of Venous Disease ◽

10.1177/0268355520988226 ◽

2021 ◽

pp. 026835552098822

Author(s):

Philip Stather ◽

Carroll Petty ◽

Helen Langthorne ◽

Emma Rayner ◽

Jufen Zhang ◽

...

Keyword(s):

Quality Of Life ◽

Feasibility Study ◽

Multicentre Trial ◽

Compression Therapy ◽

Controlled Clinical Trial ◽

Venous Ulceration ◽

Significant Difference ◽

Potential Benefits ◽

Randomised Controlled

Introduction The mainstay of treatment for venous ulceration remains compression therapy. Velcro Wrap devices are being increasingly used in these patients despite limited evidence. This feasibility study aimed to compare standard bandaging to the JuxtaCures™ Velcro wrap device. Methods A single centre, unblinded RCT compared participants with venous ulceration randomised to either the JuxtaCures™ device or short stretch bandaging. Participants were followed up for 26 weeks. Results 160 participants were screened with 40 randomised. 3 participants in bandaging and 1 in JuxtaCures™ didn’t complete the study. 60% in JuxtaCures™ healed v 55% in bandaging despite larger ulcers in the JuxtaCures™ arm (9.33 cm2 v 6.97 cm2). There was no significant difference in time to healing (12.17 v 13.64 weeks). JuxtaCures™ showed improved ulcer reduction for those that didn’t heal (14.91–5.00 cm2 v 14.20–8.62 cm2; P = 0.06). JuxtaCures™ had more consistent sub-bandage pressure dropping from 39–36 mmHg versus 41–25 mmHg in bandaging between application and removal (P < 0.001). Quality of life (EQ5D) was improved in JuxtaCures at 3 months (mean difference 0.14, p = 0.04), but not at 1 and 6 months, or in disease specific quality of life. Cost was lower in JuxtaCures™ £842.47 v £1064.68. Duration of appointment was significantly shorter in JuxtaCures™ (41 minutes v 53 minutes; P = 0.003). Conclusion This study has shown the feasibility and necessity of running a multicentre trial to evaluate the use of Velcro wrap devices for venous ulceration. It highlights the potential benefits of more consistent pressure, increased self-care, and potential with regards to ulcer healing, cost, nursing resource and quality of life.

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Characteristics Predicting the Outcome in Individuals with Diabetic Foot Ulcerations

Journal of the American Podiatric Medical Association ◽

10.7547/15-070 ◽

2017 ◽

Vol 107 (3) ◽

pp. 180-191 ◽

Cited By ~ 2

Author(s):

Lourdes Vella ◽

Cynthia Formosa

Keyword(s):

Ulcer Healing ◽

Diabetic Foot ◽

Health Care Professionals ◽

Hemoglobin A1c ◽

Foot Ulcer ◽

Patient Characteristics ◽

Outpatient Setting ◽

Foot Complications

Background: We sought to determine patient and ulcer characteristics that predict wound healing in patients living with diabetes. Methods: A prospective observational study was conducted on 99 patients presenting with diabetic foot ulceration. Patient and ulcer characteristics were recorded. Patients were followed up for a maximum of 1 year. Results: After 1 year of follow-up, ulcer characteristics were more predictive of ulcer healing than were patient characteristics. Seventy-seven percent of ulcers had healed and 23% had not healed. Independent predictors of nonhealing were ulcer stage (P = .003), presence of biofilm (P = .020), and ulcer depth (P = .028). Although this study demonstrated that the baseline hemoglobin A1c reading at the start of the study was not a significant predictor of foot ulcer outcome (P = .603, resolved versus amputated), on further statistical analyses, when hemoglobin A1c was compared with the time taken for complete ulcer healing (n = 77), it proved to be significant (P = .009). Conclusions: The factors influencing healing are ulcer stage, presence of biofilm, and ulcer depth. These findings have important implications for clinical practice, especially in an outpatient setting. Prediction of outcome may be helpful for health-care professionals in individualizing and optimizing clinical assessment and management of patients. Identification of determinants of outcome could result in improved health outcomes, improved quality of life, and fewer diabetes-related foot complications.

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Endoscopy of Nasopharyngeal Cancer

Diagnostic and Therapeutic Endoscopy ◽

10.1155/dte.1.63 ◽

1994 ◽

Vol 1 (2) ◽

pp. 63-68 ◽

Cited By ~ 3

Author(s):

Brian B. Burkey ◽

Robert H. Ossoff

Keyword(s):

Quality Of Life ◽

High Risk ◽

High Resolution ◽

Local Anesthesia ◽

Nasopharyngeal Cancer ◽

Cost Effective ◽

Cost Effective Approach ◽

The World

Nasopharyngeal cancer (NPC) is a unique disease with increasing interest for many physicians due to its unusual etiology, histology, and epidemiology. The recent era of fiberoptic endoscopy now provides the clinician with better tools for the screening, diagnosis, staging, and follow-up of NPC. The use of high resolution flexible and rigid nasopharyngoscopy gives the physician an opportunity for a more sensitive examination in a higher proportion of patients. Ultimately, this will allow for earlier diagnosis of NPC, and improved prognosis and better quality of life for the patients with this disease. Also, by allowing the clinician to perform directed biopsies of the nasopharynx under local anesthesia, fiberoptic nasopharyngoscopy allows a less morbid and more cost-effective approach towards this disease, including screening protocols in certain high risk regions of the world.

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Randomised controlled trial and economic analysis of an internet-based weight management programme: POWeR+ (Positive Online Weight Reduction)

Health Technology Assessment ◽

10.3310/hta21040 ◽

2017 ◽

Vol 21 (4) ◽

pp. 1-62 ◽

Cited By ~ 12

Author(s):

Paul Little ◽

Beth Stuart ◽

FD Richard Hobbs ◽

Jo Kelly ◽

Emily R Smith ◽

...

Keyword(s):

Primary Care ◽

Weight Loss ◽

Weight Reduction ◽

Cost Effective ◽

Health Technology ◽

Control Group ◽

Random Numbers ◽

Web Based ◽

Face To Face

BackgroundBehavioural counselling with intensive follow-up for obesity is effective, but in resource-constrained primary care settings briefer approaches are needed.ObjectivesTo estimate the clinical effectiveness and cost-effectiveness of an internet-based behavioural intervention with regular face-to-face or remote support in primary care, compared with brief advice.DesignIndividually randomised three-arm parallel trial with health economic evaluation and nested qualitative interviews.SettingPrimary care general practices in the UK.ParticipantsPatients with a body mass index of ≥ 30 kg/m2(or ≥ 28 kg/m2with risk factors) identified from general practice records, recruited by postal invitation.InterventionsPositive Online Weight Reduction (POWeR+) is a 24-session, web-based weight management intervention completed over 6 months. Following online registration, the website randomly allocated participants using computer-generated random numbers to (1) the control intervention (n = 279), which had previously been demonstrated to be clinically effective (brief web-based information that minimised pressure to cut down foods, instead encouraging swaps to healthier choices and increasing fruit and vegetables, plus 6-monthly nurse weighing); (2) POWeR+F (n = 269), POWeR+ supplemented by face-to-face nurse support (up to seven contacts); or (3) POWeR+R (n = 270), POWeR+ supplemented by remote nurse support (up to five e-mails or brief telephone calls).Main outcome measuresThe primary outcome was a modelled estimate of average weight reduction over 12 months, assessed blind to group where possible, using multiple imputation for missing data. The secondary outcome was the number of participants maintaining a 5% weight reduction at 12 months.ResultsA total of 818 eligible individuals were randomised using computer-generated random numbers. Weight change, averaged over 12 months, was documented in 666 out of 818 participants (81%; control,n = 227; POWeR+F,n = 221; POWeR+R,n = 218). The control group maintained nearly 3 kg of weight loss per person (mean weight per person: baseline, 104.4 kg; 6 months, 101.9 kg; 12 months, 101.7 kg). Compared with the control group, the estimated additional weight reduction with POWeR+F was 1.5 kg [95% confidence interval (CI) 0.6 to 2.4 kg;p = 0.001] and with POWeR+R was 1.3 kg (95% CI 0.34 to 2.2 kg;p = 0.007). By 12 months the mean weight loss was not statistically significantly different between groups, but 20.8% of control participants, 29.2% of POWeR+F participants (risk ratio 1.56, 95% CI 0.96 to 2.51;p = 0.070) and 32.4% of POWeR+R participants (risk ratio 1.82, 95% CI 1.31 to 2.74;p = 0.004) maintained a clinically significant 5% weight reduction. The POWeR+R group had fewer individuals who reported doing another activity to help lose weight [control, 47.1% (64/136); POWeR+F, 37.2% (51/137); POWeR+R, 26.7% (40/150)]. The incremental cost to the health service per kilogram weight lost, compared with the control group, was £18 (95% CI –£129 to £195) for POWeR+F and –£25 (95% CI –£268 to £157) for POWeR+R. The probability of being cost-effective at a threshold of £100 per kilogram was 88% and 98% for POWeR+F and POWeR+R, respectively. POWeR+R was dominant compared with the control group. No harms were reported and participants using POWeR+ felt more enabled in managing their weight. The qualitative studies documented that POWeR+ was viewed positively by patients and that health-care professionals generally enjoyed supporting patients using POWeR+.Study limitationsMaintenance of weight loss after 1 year is unknown.Future workIdentifying strategies for longer-term engagement, impact in community settings and increasing physical activity.ConclusionClinically valuable weight loss (> 5%) is maintained in 20% of individuals using novel written materials with brief follow-up. A web-based behavioural programme and brief support results in greater mean weight loss and 10% more participants maintain valuable weight loss; it achieves greater enablement and fewer participants undertaking other weight-loss activities; and it is likely to be cost-effective.Trial registrationCurrent Controlled Trials ISRCTN21244703.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 4. See the NIHR Journals Library website for further project information.

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Palliative radiotherapy combined with stent insertion to reduce recurrent dysphagia in oesophageal cancer patients: the ROCS RCT

Health Technology Assessment ◽

10.3310/hta25310 ◽

2021 ◽

Vol 25 (31) ◽

pp. 1-144

Author(s):

Douglas Adamson ◽

Jane Blazeby ◽

Catharine Porter ◽

Christopher Hurt ◽

Gareth Griffiths ◽

...

Keyword(s):

Quality Of Life ◽

Oesophageal Cancer ◽

External Beam Radiotherapy ◽

Palliative Radiotherapy ◽

Cost Effective ◽

Stent Insertion ◽

External Beam ◽

Bleeding Events

Background Most patients with oesophageal cancer present with incurable disease. For those with advanced disease, the mean survival is 3–5 months. Treatment emphasis is therefore on effective palliation, with the majority of patients requiring intervention for dysphagia. Insertion of a self-expanding metal stent provides rapid relief but dysphagia may recur within 3 months owing to tumour progression. Evidence reviews have called for trials of interventions combined with stenting to better maintain the ability to swallow. Objectives The Radiotherapy after Oesophageal Cancer Stenting (ROCS) study examined the effectiveness of palliative radiotherapy, combined with insertion of a stent, in maintaining the ability to swallow. The trial also examined the impact that the ability to swallow had on quality of life, bleeding events, survival and cost-effectiveness. Design A pragmatic, multicentre, randomised controlled trial with follow-up every 4 weeks for 12 months. An embedded qualitative study examined trial experiences in a participant subgroup. Setting Participants were recruited in secondary care, with all planned follow-up at home. Participants Patients who were referred for stent insertion as the primary management of dysphagia related to incurable oesophageal cancer. Interventions Following stent insertion, the external beam radiotherapy arm received palliative oesophageal radiotherapy at a dose of 20 Gy in five fractions or 30 Gy in 10 fractions. Main outcome measures The primary outcome was the difference in the proportion of participants with recurrent dysphagia, or death, at 12 weeks. Recurrent dysphagia was defined as deterioration of ≥ 11 points on the dysphagia scale of the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire oesophago-gastric module questionnaire. Secondary outcomes included quality of life, bleeding risk and survival. Results The study recruited 220 patients: 112 were randomised to the usual-care arm and 108 were randomised to the external beam radiotherapy arm. There was no evidence that radiotherapy reduced recurrence of dysphagia at 12 weeks (48.6% in the usual-care arm compared with 45.3% in the external beam radiotherapy arm; adjusted odds ratio 0.82, 95% confidence interval 0.40 to 1.68; p = 0.587) and it was less cost-effective than stent insertion alone. There was no difference in median survival or key quality-of-life outcomes. There were fewer bleeding events in the external beam radiotherapy arm. Exploration of patient experience prompted changes to trial processes. Participants in both trial arms experienced difficulty in managing the physical and psychosocial aspects of eating restriction and uncertainties of living with advanced oesophageal cancer. Limitations Change in timing of the primary outcome to 12 weeks may affect the ability to detect a true intervention effect. However, consistency of results across sensitivity analyses is robust, including secondary analysis of dysphagia deterioration-free survival. Conclusions Widely accessible palliative external beam radiotherapy in combination with stent insertion does not reduce the risk of dysphagia recurrence at 12 weeks, does not have an impact on survival and is less cost-effective than inserting a stent alone. Reductions in bleeding events should be considered in the context of patient-described trade-offs of fatigue and burdens of attending hospital. Trial design elements including at-home data capture, regular multicentre nurse meetings and qualitative enquiry improved recruitment/data capture, and should be considered for future studies. Future work Further studies are required to identify interventions that improve stent efficacy and to address the multidimensional challenges of eating and nutrition in this patient population. Trial registration Current Controlled Trials ISRCTN12376468 and Clinicaltrials.gov NCT01915693. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 31. See the NIHR Journals Library website for further project information.

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Adjustable compression wrap devices are cheaper and more effective than inelastic bandages for venous leg ulcer healing. A Multicentric Italian Randomized Clinical Experience

Phlebology The Journal of Venous Disease ◽

10.1177/0268355519858439 ◽

2019 ◽

Vol 35 (2) ◽

pp. 124-133 ◽

Cited By ~ 1

Author(s):

Giovanni Mosti ◽

Stefano Mancini ◽

Sergio Bruni ◽

Simone Serantoni ◽

Luca Gazzabin ◽

...

Keyword(s):

Ulcer Healing ◽

Ulcer Patient ◽

Cost Effective ◽

Compression Therapy ◽

Leg Ulcer ◽

Healthcare Personnel ◽

Venous Leg Ulcer ◽

Compression Pressure ◽

Correct Application ◽

Patient’S Perception

Introduction Compression therapy by inelastic bandages is highly effective in achieving venous leg ulcer healing. Inelastic bandages may be expensive as they need to be changed and discarded at every dressing change. In addition, correct application is difficult in the clinical practice, even by expert healthcare personnel. The aim of our work was to assess whether adjustable compression wraps are more cost effective and more effective than inelastic bandage to achieve venous leg ulcer healing. Methods Sixty-six venous leg ulcer patients were randomized to be treated by adjustable compression wrap (CircAid® JuxtaCure®) ( n = 33) and inelastic bandage (Coban 2 Layer®) ( n = 33). Study duration was 12 weeks. During weekly visits, the ulcers were cleansed and dressed with the same products, and the only variable was the compression device. Ulcer size, ulcer pain, patient’s perception of compression systems, and compression pressure were assessed during the visits, and the material cost was evaluated at the 12th week. Results Adjustable compression wraps were significantly cheaper than bandages (p < 0.0001) and were also more effective (not significantly) in achieving ulcer healing. To heal one ulcer patient, €228 had to be spent when applying an adjustable compression wrap and €381 if inelastic bandages were used. About 26/33 (78.8%) patients in the adjustable compression wrap group were healed after 12 weeks versus 23/33 (69.7%) in the inelastic bandage group (n.s.). Ulcer pain was reduced by both compression devices. Patient perception of compression pressure was similar with both compression devices. Compression pressure was similar at application but better maintained by adjustable compression wrap over time. Conclusions Adjustable compression wraps are significantly cheaper and more effective (not significantly) in achieving venous leg ulcer healing. Self-applicable, adjustable compression wraps are therefore a powerful, cost-effective alternative to inelastic bandages in treating venous leg ulcer.

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